PHILADELPHIA — Once-daily lixisenatide, an investigational GLP-1 agonist, was associated with significant HbA1c reduction in patients with type 2 diabetes, according to results of the GetGoal Duo 1 study.
The randomized, double blind, multicenter study was conducted to examine the safety and efficacy of the investigational drug lixisenatide (Lyxumia, Sanofi), compared with placebo, in combination with insulin glargine (Lantus, Sanofi-Aventis) and oral antidiabetic drugs. The primary endpoint was change in HbA1c from randomization.
Insulin glargine was titrated in a 12-week run-in phase to reach fasting plasma glucose between 80 mg/dL and 100 mg/dL. Patients whose HbA1c was >7% were randomly assigned to once-daily lixisenatide at 20 mcg (n=223) or placebo (n=223) for 24 weeks while insulin glargine titration continued.
Treatment with a sulfonylurea ceased at randomization. All patients were on metformin and 12% were also taking a thiazolidinedione.
During the run-in period, HbA1c decreased from 8.6% to 7.6%. The addition of lixisenatide further reduced HbA1c by a mean difference of –0.32%, compared with placebo (P<.0001). Additionally, more patients in the lixisenatide arm achieved HbA1c <7% (56% vs. 39%). Two-hour postprandial glucose was significantly improved by lixisenatide treatment after a standardized breakfast. The GLP-1 also had a beneficial effect on body weight, as compared with placebo (difference: –0.89 kg; P=.0012), despite insulin glargine titration.
Adverse events were more frequent among patients assigned to lixisenatide (80% vs. 68%). The most commonly reported events included nausea/vomiting (27.4%/9.4% vs. 4.9%/1.3%). Symptomatic hypoglycemia was also more common with lixisenatide (22.4% vs. 13.5%) More patients in the lixisenatide arm discontinued treatment due to adverse events (8.5% vs. 3.6%).
“Treatment with basal insulin and oral agents often controls fasting glucose and achieves glycemic goals for type 2 diabetes, but some patients may need additional treatment to further address postprandial hyperglycemia,” Matthew C. Riddle, MD, professor of medicine in the division of endocrinology, diabetes and clinical nutrition at Oregon Health and Science University, said in a press release.
“These results with lixisenatide are encouraging and provide scientific support as a potential approach for these patients.”
For more information:
Rosenstock J. Abstract #62-OR. Presented at: the American Diabetes Association’s 72nd Scientific Sessions; June 8-12, 2012; Philadelphia.
Disclosure: Dr. Riddle is a consultant for Amylin, Eli Lilly and Sanofi-Aventis. He receives research support from Amylin, Eli Lilly and GlaxoSmith Kline. He is on the speaker’s bureau at Sanofi-Aventis.